Научно-практический журнал Медицинские технологии. Оценка и выбор
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The Role of Inspections of Pharmaceutical Manufacturers for the Compliance with Good Manufacturing Practice in the Quality Assurance of Medicinal Products

Issue № 23 | 2016 (1)

Abstract

Pharmaceutical equivalence is an obligatory condition in the evaluation of interchangeability of compared pharmaceuticals. This implies that the maintenance of consistent quality of drugs after their registration is a crucial element of assuring this interchangeability. Pharmaceutical inspections are the main instrument of the monitoring of compliance with GMP. After the adoption of the Decree of the Government of the Russian Federation no. 1314 of 3 December 2015, it seems necessary to evaluate the conformity of the introduced system of inspections with the current international practice.

Keywords

interchangeability, good manufacturing practice, GMP, pharmaceutical equivalence, inspection.

For citations

Meshkovskiy A.P. The Role of Inspections of Pharmaceutical Manufacturers for the Compliance with Good Manufacturing Practice in the Quality Assurance of Medicinal Products. Medical Technologies. Assessment and Choice. 2016; 1(23): 81–88.

mt_23_2016-1_81-88